Angina, UnstableNCT00354328
Heart Function and Exercise Capacity in Patients With Hypertrophic Cardiomyopathy
An observational study of Angina, Unstable and Myocardial Infarction, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial summary
This study will examine the relationship between certain measures of heart function and exercise capacity in patients with hypertrophic cardiomyopathy (HCM). Patients who participated in NHLBI studies 01-H-0006 ("Double Blind Placebo-Controlled Study of Pirfenidone - A Novel Anti-Fibrotic Drug - in Symptomatic… Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Angina, Unstable, Myocardial Infarction, Ischemic Heart Disease
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 27 May 2005to 22 Oct 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
- Eligibility criteria not listed; Analysis of data from previous studies.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Relationship of Diastolic Function and Functional Capacity in Hypertrophic Cardiomyopathy: A Post-Hoc Analysis of Protocols 01-H-0066 and 96-H-0144
This study will examine the relationship between certain measures of heart function and exercise capacity in patients with hypertrophic cardiomyopathy (HCM).
Patients who participated in NHLBI studies 01-H-0006 ("Double Blind Placebo-Controlled Study of Pirfenidone - A Novel Anti-Fibrotic Drug - in Symptomatic Patients with Hypertrophic Cardiomyopathy Associated with Left Ventricular Diastolic Dysfunction") and 96-H-0144 ("Double Blind Placebo-Controlled Study of Long-Term Effects of Angiotensin-Converting Enzyme Inhibition (Enalapril) and Angiotensin II Receptor Blockade (Losartan) on Genetically-Induced Left Ventricular Diastolic Dysfunction") are eligible for this study. Data from echocardiograms and measures of left ventricular pressure obtained from patients in those studies will be analyzed in the current study to assess their influence on exercise capacity. No additional tests, treatments or other procedures are required.
Information from this study may help in the development of improved drug treatments for HCM.
Read the detailed description
NIH Protocols 01-H-0066, Double Blind Placebo Controlled Study of Pirfenidone A Novel Anti-Fibrotic Drug in Symptomatic patients with Hypertrophic Cardiomyopathy (HCM) Associated with left Ventricular Diastolic Dysfunction and 96-H-0144, Double Blind Placebo-Controlled Study of Long-Term Effects of Angiotensin Converting Enzyme Inhibition (Enalapril) and Angiotensin II Receptor Blockade (Losartan) On Genetically-Induced Left Ventricular Diastolic Dysfunction were undertaken to assess the effect of therapeutic interventions on left ventricular (LV) diastolic function. The relationship between baseline measures of diastolic function as assessed by noninvasive modalities such as Doppler echocardiography and radionuclide angiography, and qualitative and objective measures of functional capacity in patients without LV outflow tract obstruction has not been reported. In this protocol we will look at measures of LV geometry, relaxation and novel indices of ventricular compliance as they may influence measures of exercise capacity. In all cases, we will use pre-existing baseline data obtained with informed consent as part of the above protocols.
- Keywords
- HCM, Echocardiography, Diastolic Dysfunction, Enalapril
- Medical subject headings
- Angina, Unstable, Myocardial Infarction, Myocardial Ischemia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2006 (estimated)
- Study start27 May 2005
- Study completion22 Oct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Angina, UnstableStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Dorothea R McAreavey, M.D., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00354328
- Sponsor's protocol ID
- 050163
- Other IDs
- 05-H-0163
- Status last verified
- Oct 2017
- First submitted
- 18 Jul 2006
- Last updated
- 5 Oct 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship of Diastolic Function and Functional Capacity in Hypertrophic Cardiomyopathy: A Post-Hoc Analysis of Protocols 01-H-0066 and 96-H-0144
- ClinicalTrials.gov ID
- NCT00354328
- Acronym / sponsor ID
- 050163
- Keywords
- HCM, Echocardiography, Diastolic Dysfunction, Enalapril
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- 27 May 2005
- Study completion
- 22 Oct 2013
- First posted
- 20 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will examine the relationship between certain measures of heart function and exercise capacity in patients with hypertrophic cardiomyopathy (HCM).
Patients who participated in NHLBI studies 01-H-0006 ("Double Blind Placebo-Controlled Study of Pirfenidone - A Novel Anti-Fibrotic Drug - in Symptomatic Patients with Hypertrophic Cardiomyopathy Associated with Left Ventricular Diastolic Dysfunction") and 96-H-0144 ("Double Blind Placebo-Controlled Study of Long-Term Effects of Angiotensin-Converting Enzyme Inhibition (Enalapril) and Angiotensin II Receptor Blockade (Losartan) on Genetically-Induced Left Ventricular Diastolic Dysfunction") are eligible for this study. Data from echocardiograms and measures of left ventricular pressure obtained from patients in those studies will be analyzed in the current study to assess their influence on exercise capacity. No additional tests, treatments or other procedures are required.
Information from this study may help in the development of improved drug treatments for HCM.
Detailed description
NIH Protocols 01-H-0066, Double Blind Placebo Controlled Study of Pirfenidone A Novel Anti-Fibrotic Drug in Symptomatic patients with Hypertrophic Cardiomyopathy (HCM) Associated with left Ventricular Diastolic Dysfunction and 96-H-0144, Double Blind Placebo-Controlled Study of Long-Term Effects of Angiotensin Converting Enzyme Inhibition (Enalapril) and Angiotensin II Receptor Blockade (Losartan) On Genetically-Induced Left Ventricular Diastolic Dysfunction were undertaken to assess the effect of therapeutic interventions on left ventricular (LV) diastolic function. The relationship between baseline measures of diastolic function as assessed by noninvasive modalities such as Doppler echocardiography and radionuclide angiography, and qualitative and objective measures of functional capacity in patients without LV outflow tract obstruction has not been reported. In this protocol we will look at measures of LV geometry, relaxation and novel indices of ventricular compliance as they may influence measures of exercise capacity. In all cases, we will use pre-existing baseline data obtained with informed consent as part of the above protocols.
Study design
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2018.
Related trials for Angina, Unstable
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Recruiting
Invasive Evaluation and Phenotype-Guided Treatment of ANOCA in Women
ANOCA - Angina With Non-obstructive Coronary Arteries, Coronary Microvascular Dysfunction (CMD)
RecruitingObservational study
Analysis of Life-threatening ARrhythMias After Acute Coronary Syndrome
Acute Coronary Syndromes (ACS), Ventricular Tachycardia (VT)
RecruitingObservational study
Gangwon PCI Prospective Registry
Coronary Artery Disease, Ischemic Heart Disease (IHD)
Active, not recruiting
Emergency Department Triage of Patients With Acute Chest Pain Based on the ESC 0/1-hour Algorithm (PRESC1SE-MI)
Acute Chest Pain, NSTEMI - Non-ST Segment Elevation MI
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dorothea R McAreavey, M.D. principal investigator
National Institutes of Health Clinical Center (CC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Angina, Unstable and Myocardial Infarction, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2018.