Heart Failure, DiastolicNCT02649400
Assessment of Functional Capacity and Inflammatory Markers in Women With Heart Failure With Preserved Ejection Fraction
An observational study of Heart Failure, Diastolic and Coronary Artery Disease, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
This study assesses the impact of diastolic heart failure on exercise capacity in women who have a previous coronary condition. All the participants will go through the same evaluation. Read more about this study
- Who is it for?
- Ages 35 to 70 years, women only
- Conditions the study is for
- Heart Failure, Diastolic, Coronary Artery Disease, Inflammation
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2013to Aug 2014
- 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 35 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with coronary artery disease diagnosed through angiography and heart failure with preserved ejection fraction diagnosed via ecocardiography.
Who may be able to join
- Women;
- Aged between 35 and 70 years;
- Coronary artery disease proven by coronary angiography;
- Diastolic heart failure confirmed by recent echocardiography (6 months);
- Left Ventricle ejection fraction of greater than 50%;
- Absence of acute or chronic pulmonary disease;
- Patient clinically compensated;
- Consent form signed for participation in the research
Who cannot join
- Inability to perform spirometry;
- Presence of acute or chronic pulmonary disease;
- Chronic inflammatory disease, kidney or liver disease;
- Patients using corticosteroids, aspirin or other nonsteroidal anti-inflammatory;
- Clinical or laboratory evidence of infection;
- Morbid obesity;
- Hemodynamic instability at the time of spirometry;
- Patient's or legal guardian request to leave at any time of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Functional Capacity, Inflammatory Markers and Autonomic Function in Women With Heart Failure With Preserved Ejection Fraction and Previous Coronary Artery Disease
This study assesses the impact of diastolic heart failure on exercise capacity in women who have a previous coronary condition. All the participants will go through the same evaluation.
Read the detailed description
It is well established that systolic heart failure impacts exercise capacity and quality of life, diastolic heart failure however, is not well documented as a condition that reduces physical performance.
To confirm that patients have a diastolic disfunction an echocardiography will be performed, this will also yield the left ventricle ejection fraction to confirm the preserved ejection fraction heart failure diagnostics.
Exercise capacity will be assessed using the distance walked on the six-minute walking test, performed on a 30m corridor.
Pulmonary function will be assessed with spirometry and values of forced vital capacity and forced expired volume in one second will be recorded and compared to the age-predicted values.
Respiratory strength will be determined by maximal pressure achieved on a respiratory manometer.
Peripheral muscular strength will be assessed with a handheld dynamometer. Knee extension strength of the dominant leg will be recorded.
An echocardiography will be performed to assess systolic and diastolic function and ejection fraction.
Heart autonomic function will be evaluated using a heart rate monitor and a computer software to identify the sympathovagal balance.
- Medical subject headings
- Heart Failure, Diastolic, Coronary Artery Disease, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Diastolic Heart Failure | Women with diastolic heart failure and previous coronary artery disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Capacity
Measured by the distance walked in the six-minute walking test in meters.
Measured: Up to 1 year after diagnosis
Inflammatory markers
Inflammatory markers evaluated using specific assays for blood analysis Interleukin (IL) 1 (pg/mL), IL-6 (pg/mL), IL 8 (pg/mL),Tumor Necrosis Factor alpha (pg/mL), Brain Natriuretic Peptide (BNP) (pg/mL), pro-BNP (pg/mL);
Lab results will be analysed for each marker and values will be compared to laboratory reference data to identify values out of range.
Measured: Up to 1 year after diagnosis on the same day as functional capacity assessment
Inflammatory Markers
Inflammatory markers evaluated using specific assays for blood analysis for high sensitivity C reactive protein (mg/L), alpha-1-acid glycoprotein (mg/dL) and platelets (platelets/cubic millimeters), lactate (mg/dL), uric acid (mg/dL)
Measured: Up to 1 year after diagnosis on the same day as functional capacity assessment
Secondary outcomes (5)
Heart autonomic function
Sympathovagal balance assessed by heart rate variability using a heart monitor
Measured: Up to 1 year after diagnosis on the same day as functional capacity assessment
Quality of life
Quality of life assessed by the Minnesota questionnaire specific for heart failure
Measured: Up to 1 year after diagnosis on the same day as functional capacity assessment
Pulmonary function
Pulmonary function assessed by spirometry for obtaining values of forced expired volume in one second (FEV1), forced vital capacity (FVC) and FEV1/FVC ratio
Measured: Up to 1 year after diagnosis on the same day as functional capacity assessment
Respiratory muscle strength
Respiratory muscle strength assessed by manometer for obtaining maximal inspiratory pressure and maximal expiratory pressure values in cmH2O.
Measured: Up to 1 year after diagnosis on the same day as functional capacity assessment
Peripheral muscle strength
Peripheral muscle strength assessed by the quadriceps strength using a portable dynamometer in kilogram-force (kgf)
Measured: Up to 1 year after diagnosis on the same day as functional capacity assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2016 (estimated)
- Study startAug 2013
- Primary completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure, DiastolicStudies of the same condition, open and under way.
- 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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Figueiredo Alves da Silva, Federal University of São Paulo
- Investigators
- Daniel Figueiredo Alves da Silva, PT, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02649400
- Sponsor's protocol ID
- 15218913.6.0000.5505
- Status last verified
- Jan 2016
- First submitted
- 2 Dec 2015
- Last updated
- 12 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Functional Capacity, Inflammatory Markers and Autonomic Function in Women With Heart Failure With Preserved Ejection Fraction and Previous Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT02649400
- Acronym / sponsor ID
- 15218913.6.0000.5505
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Aug 2014 (actual)
- First posted
- 7 Jan 2016 (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 assesses the impact of diastolic heart failure on exercise capacity in women who have a previous coronary condition. All the participants will go through the same evaluation.
Detailed description
It is well established that systolic heart failure impacts exercise capacity and quality of life, diastolic heart failure however, is not well documented as a condition that reduces physical performance.
To confirm that patients have a diastolic disfunction an echocardiography will be performed, this will also yield the left ventricle ejection fraction to confirm the preserved ejection fraction heart failure diagnostics.
Exercise capacity will be assessed using the distance walked on the six-minute walking test, performed on a 30m corridor.
Pulmonary function will be assessed with spirometry and values of forced vital capacity and forced expired volume in one second will be recorded and compared to the age-predicted values.
Respiratory strength will be determined by maximal pressure achieved on a respiratory manometer.
Peripheral muscular strength will be assessed with a handheld dynamometer. Knee extension strength of the dominant leg will be recorded.
An echocardiography will be performed to assess systolic and diastolic function and ejection fraction.
Heart autonomic function will be evaluated using a heart rate monitor and a computer software to identify the sympathovagal balance.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diastolic Heart Failure | – | –Women with diastolic heart failure and previous coronary artery disease |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with coronary artery disease diagnosed through angiography and heart failure with preserved ejection fraction diagnosed via ecocardiography.
Key inclusion criteria (8 listed)
- Women;
- Aged between 35 and 70 years;
- Coronary artery disease proven by coronary angiography;
- Diastolic heart failure confirmed by recent echocardiography (6 months);
- Left Ventricle ejection fraction of greater than 50%;
Key exclusion criteria (8 listed)
- Inability to perform spirometry;
- Presence of acute or chronic pulmonary disease;
- Chronic inflammatory disease, kidney or liver disease;
- Patients using corticosteroids, aspirin or other nonsteroidal anti-inflammatory;
- Clinical or laboratory evidence of infection;
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
Functional Capacity
Time frame: Up to 1 year after diagnosis
Measured by the distance walked in the six-minute walking test in meters.
Inflammatory markers
Time frame: Up to 1 year after diagnosis on the same day as functional capacity assessment
Inflammatory markers evaluated using specific assays for blood analysis Interleukin (IL) 1 (pg/mL), IL-6 (pg/mL), IL 8 (pg/mL),Tumor Necrosis Factor alpha (pg/mL), Brain Natriuretic Peptide (BNP) (pg/mL), pro-BNP (pg/mL); Lab results will be analysed for each marker and values will be compared to laboratory reference data to identify values out of range.
Inflammatory Markers
Time frame: Up to 1 year after diagnosis on the same day as functional capacity assessment
Inflammatory markers evaluated using specific assays for blood analysis for high sensitivity C reactive protein (mg/L), alpha-1-acid glycoprotein (mg/dL) and platelets (platelets/cubic millimeters), lactate (mg/dL), uric acid (mg/dL)
5 secondary outcomes
Heart autonomic function
Time frame: Up to 1 year after diagnosis on the same day as functional capacity assessment
Quality of life
Time frame: Up to 1 year after diagnosis on the same day as functional capacity assessment
Pulmonary function
Time frame: Up to 1 year after diagnosis on the same day as functional capacity assessment
Respiratory muscle strength
Time frame: Up to 1 year after diagnosis on the same day as functional capacity assessment
Peripheral muscle strength
Time frame: Up to 1 year after diagnosis on the same day as functional capacity assessment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2016.
- Individual participant dataSharing planned: No
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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.
Daniel Figueiredo Alves da Silva, PT principal investigator
Federal University of São Paulo
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 Heart Failure, Diastolic and Coronary Artery Disease, run by Federal University of São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 12 Jan 2016. 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 Brazil. 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?
Results are not available in the source record.
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.
What does the primary outcome measure?
Functional Capacity (time frame: Up to 1 year after diagnosis). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 12 Jan 2016.