A Pilot study to assess the effects of beta-blockade on exercise capacity and BNP levels in patients with predominantly diastolic heart failure
- Conditions
- Diastolic heart failure
- Registration Number
- EUCTR2004-004169-13-GB
- Lead Sponsor
- south manchester university hospital nhs trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 40
All patients must satisfy all of the following criteria to be entered into the study.
1) Evidence or history of clinical heart failure.
2) Ejection fraction of >45%.
3) Raised Plasma BNP levels.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1) Clinical evidence of pulmonary or peripheral oedema.
2) History of asthma or significant reversible chronic obstructive airways disease (reversibility in FEV1 of > 15%)
3) Hypotension (BP < 100/60)
4) Significant bradycardia (heart rate < 55 bpm), 2nd or 3rd degree AV block.
5) History of intolerance to beta-blocker treatment.
6) Diagnosis of constrictive pericarditis.
7) Presence of severe peripheral vascular disease.
10) Myocardial infarction within 3 months prior to enrolment.
11) Female patients, who are pregnant, breast feeding or planning pregnancy during the course of the study.
12) Use of any investigational drug within 2 weeks of enrolment into the study.
13) Recent changes (less than 2 weeks) in cardiac medications other than that instituted by the investigators.
14) Significant co. morbid disease with a limited prognosis such that likely period of survival from the co morbidity is less than a year.
15) Clinically significant abnormality identified on screening history, physical examination, laboratory tests, ECG or Echocardiogram, which in the judgment of the investigator would preclude safe completion of the study.
16) An indication of beta-blocker treatment arises during the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the effect of beta-blocker treatment in diastolic heart failure.;Secondary Objective: ;Primary end point(s): 1) The primary efficacy variable is the change from baseline in plasma BNP measurements<br>2) The secondary efficacy variable is distance walked during 6-minute walk test, a change from baseline serum CRP and interleukin 6 levels. <br><br>
- Secondary Outcome Measures
Name Time Method