NCT01935622

Brief Summary

Non-ischemic cardiomyopathy and heart failure are highly influenced by the presence of systemic inflammation. Doxycycline is a FDA-approved drug to treat bacterial infections which also shows powerful anti-inflammatory effects. In this study we plan to determine the effects of Doxycycline in patients with stable heart failure and non-ischemic cardiomyopathy on peak of aerobic exercise capacity (peak V02) and ventilator efficiency measured with a cardiopulmonary test.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2012

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 23, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 5, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
3 months until next milestone

Results Posted

Study results publicly available

August 20, 2014

Completed
Last Updated

August 20, 2014

Status Verified

August 1, 2014

Enrollment Period

1.9 years

First QC Date

August 23, 2013

Results QC Date

June 20, 2014

Last Update Submit

August 19, 2014

Conditions

Non-ischemic CardiomyopathySystolic Heart Failure (NYHA II-III)

Keywords

heart failurenon-ischemic cardiomyopathy

Outcome Measures

Primary Outcomes (1)

  • Peak Aerobic Exercise Capacity

    Interval change in peak VO2 measured at cardiopulmonary test

    14 days

Study Arms (3)

Doxycycline 100 mg

EXPERIMENTAL

Doxycycline 100 mg twice daily for 14 days

Drug: Doxycycline

Doxycycline 20 mg

EXPERIMENTAL

Doxycycline 20 mg twice daily for 14 days

Drug: Doxycycline

Placebo

PLACEBO COMPARATOR

Placebo

Drug: placebo

Interventions

DoxycyclineDRUG

Doxycycline 1 tablet every 12 hours for 14 days

Doxycycline 100 mgDoxycycline 20 mg
placeboDRUG

Placebo 1 tablet every 12 hours for 14 days

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Non-ischemic cardiomyopathy (LVEF\<40%)
  • Heart failure NYHA II-III

You may not qualify if:

  • Age \<18
  • Recent changes (previous 3 months) in HF maintenance medications (beta-blockers, angiotensin converting enzyme \[ACE\] inhibitors, aldosterone antagonists, vasodilators, cardiac glycosides, diuretics)
  • Hospitalization for worsening HF or acute decompensated HF within the previous 12 months
  • History of coronary or ischemic heart disease
  • Anticipated need for cardiac resynchronization therapy (CRT) or automated-implantable cardioverter defibrillator (AICD) or coronary revascularization or cardiac surgery
  • Angina or electrocardiograph (ECG) changes that limit maximum exertion during cardiopulmonary exercise testing
  • Active infection including chronic infection
  • Active cancer (or prior diagnosis of cancer within the past 10 years)
  • Recent (\<14 days) use of anti-inflammatory drugs (not including NSAIDs), Chronic inflammatory disorder (including but not limited to rheumatoid arthritis, systemic lupus erythematosus), malignancy, or any comorbidity limiting survival or ability to complete the study
  • Pregnancy
  • Inability to give informed consent
  • Other conditions limiting completion of cardiopulmonary exercise test or completion of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Heart Failure, SystolicHeart Failure

Interventions

Doxycycline

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

TetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Limitations and Caveats

(No data analysis conducted. Insufficient enrollment)

Results Point of Contact

Title
Antonio Abbate
Organization
Virginia Commonwealth University
aabbate@vcu.edu
8048280513

Study Officials

  • Antonio Abbate, M.D.

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2013

First Posted

September 5, 2013

Study Start

July 1, 2012

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

August 20, 2014

Results First Posted

August 20, 2014

Record last verified: 2014-08

Locations

US(1)