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临床试验/NCT01742702
NCT01742702招募中不适用

Non-Invasive HaemoDYNAMICs in Primary and Secondary Hypertension: the DYNAMIC-study

Tampere University2 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2006年5月25日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
2,000
试验地点
2
主要终点
Change in haemodynamic variables during the follow-up

研究概览

简要总结

The primary aim of the present study was to examine the haemodynamic changes in primary hypertension and secondary hypertension (renal diseases, endocrine diseases, obesity-associated hypertension) with a non-invasive haemodynamic measurement protocol utilizing radial pulse wave analysis and whole-body impedance cardiography in both supine position and during head-up tilt. For comparison, haemodynamics of subjects with chronic fatigue syndrome will also be recorded.

详细描述

Elevated blood pressure (BP) and related cardiovascular complications are the leading causes of morbidity and mortality in the modern world. In routine clinical practice, the haemodynamic status is commonly assessed by measuring heart rate and blood pressure at rest, which provides only limited information about functional haemodynamic status. In addition, the haemodynamic changes resulting in similar elevations of BP may differ substantially between patients and disorders.

Therefore, we investigated the haemodynamic changes in primary and secondary hypertension and in the control subjects with non-invasive radial pulse wave analysis and whole-body impedance cardiography. The method includes the determination of volume status using bioimpedance spectroscopy, determination of peripheral and central BP, cardiac function, vascular resistance, arterial compliance and indices of pulse wave reflection. Besides the measurements performed in the supine position, passive orthostatic challenge is included in the protocol to assess the upright functional haemodynamic status.

The repeatability and reproducibility of the protocol was first examined with a double-blind, randomized protocol in 35 subjects (methodological study group), and after that the administration of research drugs has been open-label. The effects of single doses of two largely endothelium-dependent agents, inhaled salbutamol and intravenous L-arginine, and one endothelium-independent agent, sublingual nitroglycerin, were investigated. However, challenges with the acute dosing of all medical compounds was terminated at the end of December 2016. Thereafter, the measurement protocol has included supine and upright recordings on the tilt-table, followed by supine measurements during paced breathing (15 breaths per minute for 5 minutes, 6 breaths per minute for 5 minutes) that modulate the autonomic nervous tone.

The study population has consisted of subgroups described below. The study protocol of each subgroup has been approved by the ethics committee of the Pirkanmaa Hospital District (Ethics committee ID's above), and the administration of research drugs has also been approved by the Finnish Agency for Medicines (EudraCT-numbers above).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Independent, community-dwelling adults
  • Hypertensive subjects (primary or secondary hypertension)
  • Normotensive control subjects
  • Subjects with aortic stenosis (subgroup "aortic stenosis")
  • Participants of Ironman Triathlon competition

排除标准

  • Pregnancy
  • Systolic blood pressure <90 mmHg
  • Allergies to test compounds

研究组 & 干预措施

AERO-DYNAMIC (recordings completed)

Subjects who had voluntarily decided to participate in a professionally coached marathon school (Varala Sports Institute, Tampere) were given the chance for haemodynamic recordings before, during and after the training protocol.

干预措施: Nitroglycerin 0.25 mg (single dose, no longer given since January 2017) (Drug)

AERO-DYNAMIC (recordings completed)

Subjects who had voluntarily decided to participate in a professionally coached marathon school (Varala Sports Institute, Tampere) were given the chance for haemodynamic recordings before, during and after the training protocol.

干预措施: Salbutamol 400 µg (single dose, no longer given since January 2017) (Drug)

Liquorice (recordings completed)

Normotensive subjects, daily liquorice ingestion (daily glycyrrhizin dose 290-370 mg) for 2 weeks, haemodynamic measurements before and after the intervention.

干预措施: Nitroglycerin 0.25 mg (single dose, no longer given since January 2017) (Drug)

Liquorice (recordings completed)

Normotensive subjects, daily liquorice ingestion (daily glycyrrhizin dose 290-370 mg) for 2 weeks, haemodynamic measurements before and after the intervention.

干预措施: Salbutamol 400 µg (single dose, no longer given since January 2017) (Drug)

Liquorice (recordings completed)

Normotensive subjects, daily liquorice ingestion (daily glycyrrhizin dose 290-370 mg) for 2 weeks, haemodynamic measurements before and after the intervention.

干预措施: Liquorice (2 weeks, glycyrrhizin 290-370 mg daily, no longer given since 2012) (Dietary Supplement)

Milk polypeptides (recordings completed)

Daily ingestion of yoghurt containing small milk casein-derived polypeptides for 12 weeks versus placebo yoghurt.

干预措施: Small milk casein-derived polypeptides (12 weeks daily, recordings completed 2011) (Dietary Supplement)

Bisoprolol (recordings completed)

Hypertensive subjects, bisoprolol 5 mg once daily versus placebo in a double-blind, cross-over protocol.

干预措施: Nitroglycerin 0.25 mg (single dose, no longer given since January 2017) (Drug)

Bisoprolol (recordings completed)

Hypertensive subjects, bisoprolol 5 mg once daily versus placebo in a double-blind, cross-over protocol.

干预措施: Salbutamol 400 µg (single dose, no longer given since January 2017) (Drug)

Bisoprolol (recordings completed)

Hypertensive subjects, bisoprolol 5 mg once daily versus placebo in a double-blind, cross-over protocol.

干预措施: Bisoprolol (5 mg daily for 3 weeks, recordings completed 2011) (Drug)

Methodological (recordings completed)

35 normotensive subjects who received research drugs (nitroglycerin, salbutamol, placebo resoriblet, placebo inhalation, L-arginine infusion, saline infusion) in a placebo-controlled, double-blinded manner

干预措施: Nitroglycerin 0.25 mg (single dose, no longer given since January 2017) (Drug)

Methodological (recordings completed)

35 normotensive subjects who received research drugs (nitroglycerin, salbutamol, placebo resoriblet, placebo inhalation, L-arginine infusion, saline infusion) in a placebo-controlled, double-blinded manner

干预措施: Salbutamol 400 µg (single dose, no longer given since January 2017) (Drug)

Methodological (recordings completed)

35 normotensive subjects who received research drugs (nitroglycerin, salbutamol, placebo resoriblet, placebo inhalation, L-arginine infusion, saline infusion) in a placebo-controlled, double-blinded manner

干预措施: L-arginine (10 min infusion, no longer given since January 2017) (Drug)

结局指标

主要结局

Change in haemodynamic variables during the follow-up

时间窗: baseline, ten years

Haemodynamic measurements are performed at baseline, and after approximately 10 years of follow-up

Cardiovascular events

时间窗: ten years of follow-up

All cardiovascular events during follow-up

次要结局

  • Haemodynamic response to head-up tilt and research drugs(0, 5, 10, 15, 20, 25 and 30 minutes)
  • Haemodynamic response to bisoprolol or dietary supplements (liquorice, milk casein-derived polypeptides)(baseline and after 2 weeks (liquorice); 3 weeks (bisoprolol), or 12 weeks (polypeptides))
  • Haemodynamic changes induced by Ironman competition(Recordings within 2 hours after completion Ironman competition, 12-18 hours later, and within 1-4 before or 4-8 weeks after the competition)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ilkka Pörsti, MD

MD, PhD, Professor of Internal Medicine

Tampere University

研究点 (2)

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