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Use of Beta-agonists in Stable Severe Congestive Heart Failure

NCT ID: NCT01447069

Last Updated: 2011-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2012-03-31

Brief Summary

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The purpose of this study is to determine whether Salbutamol is effective in the treatment of severe heart failure due to ischemic and non- ischemic cardiomyopathy.

Detailed Description

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Conditions

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Ischemic Cardiomyopathy Non-ischemic Cardiomyopathy Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Salbutamol

The patients in the study groups will receive the selective β2 agonist, Salbutamol, in addition to their ongoing optimal heart failure therapy.

Group Type ACTIVE_COMPARATOR

Salbutamol

Intervention Type DRUG

The initial dose will be 0.5mg bid, with acceleration of the dose every two weeks by 1mg, up to a maximal dose of 2mg bid or an increase in heart rate by 50% above the baseline heart rate, as long as it remains \<100 bpm

control

The patients in the control group will continue with their regular optimal medical therapy without any intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Salbutamol

The initial dose will be 0.5mg bid, with acceleration of the dose every two weeks by 1mg, up to a maximal dose of 2mg bid or an increase in heart rate by 50% above the baseline heart rate, as long as it remains \<100 bpm

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Ambulatory Patients with a diagnosis of ischemic and non-ischemic cardiomyopathy with a measured EF \<35%, class III as defined by the NYHA with ICD and who receive optimal pharmacological therapy.

Exclusion Criteria

* Heart Failure class I, II, IV
* atrial fibrillation
* any significant valvular disease
* chronic obstructive pulmonary disease who treated with inhaled β2 agonist
* significant kidney disease with eGFR \<30%
* severe uncontrolled electrolyte abnormalities
* prior allergic reaction to Salbutamol
* Pregnancy and nursing women
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rabin Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Rabin medical center

Petah Tikva, , Israel

Site Status

Countries

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Israel

Central Contacts

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Zaza Iakobishvili, MD

Role: CONTACT

[email protected]
972-3-937100

Tuvia Ben Gal, MD

Role: CONTACT

[email protected]
972-3-6930

Facility Contacts

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Zaza Iakobishvili, MD

Role: primary

[email protected]
972-3-9377100

Tuvia Ben Gal, MD

Role: backup

[email protected]
972-3-9376930

Other Identifiers

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BTA-HF-01

Identifier Type: -

Identifier Source: org_study_id