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Clinical Trials/EUCTR2004-004169-13-GB
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

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.

Registry
who.int
Start Date
April 21, 2005
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
south manchester university hospital nhs trust

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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