Assessment of the Effects of Cardiopulmonary Phenotype on Oral and intravenous (IV) Frusemide Pharmacokinetics

Phase 4

Recruiting

• Conditions: Congestive Heart Failure; Pulmonary Hypertension; Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system

• Registration Number: ACTRN12614000461695
• Lead Sponsor: Flinders University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-05-02
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Adult males and females over the age of 18 years being treated for either acutely decompensated congestive heart failure or pulmonary hypertension by the appropriate physician specialists.

Potential study participants will be enrolled into the respective arms of the study (acutely decompensated congestive heart failure or pulmonary hypertension) on the basis of clinician assessment of the following variables:

Acutely decompensated congestive heart failure referred from the cardiology clinic:
* Documented reduced ejection fraction (<45%).
* Presence of at least one symptom (dyspnoea, orthopnoea, fatigue or oedema) and
* Presence of at least one sign (rales, peripheral oedema, ascites, or pulmonary vascular congestion on chest radiography) of heart failure.

Pulmonary hypertension referred from the pulmonary hypertension clinic and requiring frusemide to alleviate the congestion caused by right heart failure:
* Documented elevation of pulmonary arterial pressures (either noninvasively by echocardiogram or invasively by right heart catheterization) >25 mmHg
* Documented normal ejection fraction (>50%), and
* Presence of at least one sign (lower limb oedema or ascites) of pulmonary hypertension.

Compensated heart failure will be recognised by:
* The assessment of the treating clinical team but should include: improvement of the principal symptom and improvement in signs of decompensated CHF

Exclusion Criteria

Clinical symptoms: systolic blood pressure of less than 90mmHg, serum creatinine level >300microg/L, co-administered intravenous vasodilators or inotropic agents (other than digoxin). Documented ischaemic heart disease or systemic hypertension (pulmonary hypertension group only).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The change in blood and urine concentrations-time profiles for frusemide following oral administration in patients during decompensated- and compensated- congestive heart failure. [Sampling will occur hourly 6 hours following oral frusemide administration.];The change in blood and urine concentrations-time profiles for frusemide following intravenous administration in patients during decompensated- and compensated- congestive heart failure. [Sampling will occur hourly for 6 hours following intravenous frusemide administration. ]

Secondary Outcome Measures

Name	Time	Method
The impact on blood and urine concentrations-time profiles for frusemide following oral administration in patients with oedema secondary to pulmonary hypertension.[Sampling will occur hourly for 6 hours following oral frusemide administration];The impact on blood and urine concentrations-time profiles for frusemide following intravenous administration in patients with oedema secondary to pulmonary hypertension.[Sampling will occur hourly for 6 hours following intravenous frusemide administration]