EUCTR2004-004169-13-GB
Active, not recruiting
Phase 1
A Pilot study to assess the effects of beta-blockade on exercise capacity and BNP levels in patients with predominantly diastolic heart failure
south manchester university hospital nhs trust0 sites40 target enrollmentApril 21, 2005
DrugsCardicor
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- south manchester university hospital nhs trust
- Enrollment
- 40
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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