Using Cardiovascular Magnetic Resonance Tissue Characterisation and Wearable Technology to PREDICT Clinical Outcomes, Response to Therapy and Arrhythmias in Hospitalised Heart Failure Patients (PREDICT-HF)
Using Cardiovascular Magnetic Resonance Tissue Characterisation and Wearable Technology to Predict Clinical Outcomes, Response to Therapy and Arrhythmias in Hospitalised Heart Failure Patients
150 patients admitted to University Hospital Southampton with heart failure will undergo comprehensive Cardiovascular Magnetic Resonance (CMR) imagining during their admission and continuous heart rhythm monitoring using wearable technology post discharge.
We hypothesise that analysis of this outcome data will discover novel CMR tissue characterisation and heart rhythm biomarkers that can be used to predict adverse clinical outcomes in heart failure populations and how individual patients will respond to specific therapies.
調査の概要
状態
詳細な説明
PREDICT-HF a low risk single centre observational study in which 150 consecutive patients admitted with a new, primary diagnosis of heart failure undergo advanced CMR to non-invasively establish their individual myocardial tissue characteristics during their initial presentation.
All study participants will be invited to participate in an optional heart rhythm and rate monitoring sub study which will involve continuous electrocardiographic monitoring for up to 2 days prior to discharge and up to 30 day immediately post discharge using a Samsung S-PATCH device.
To enable multivariate statistical analysis to be performed each study participant will undergo a range of validated investigation to comprehensively establish and monitor other recognised heart failure prognostic biomarkers.
Participants will be managed per current NICE heart failure guidelines and will undergo rigorous clinical reviews at 6, 12 and 24 months. All clinically relevant event data e.g. MACE, rehospitalisation, decompensation and arrhythmias will be meticulously recorded for each participant throughout the study period.
This study will identify novel CMR derived tissue characterisation biomarkers of adverse outcome, response to therapy and arrhythmias in a hospitalised heart failure population. It will also be the first study to utilise wearable heart monitoring technology to accurately record heart rate and rhythm data in this population and investigate the potential impact of this on patient's clinical management and outcomes.
研究の種類
入学 (予想される)
連絡先と場所
研究場所
-
-
Hampshire
-
Southampton、Hampshire、イギリス、SO166YD
- 募集
- University Hospital Southampton
-
コンタクト：
- Andrew Flett, MBBS MD(Res) MRCP BSc(Hons)
- 電話番号：02381205906
- メール：andrew.flett@uhs.nhs.uk
-
コンタクト：
- Robert Adam, MBBS MRCP BSc(Hons)
- 電話番号：6744 02380777222
- メール：robert.adam@uhs.nhs.uk
-
主任研究者：
- Andrew Flett, MBBS MD(Res) MRCP BSc(Hons)
-
副調査官：
- Robert Adam, MBBS MRCP BSc(Hons)
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
All patients admitted to University Hospital Southampton with a new primary diagnosis of heart failure will be considered for the study.
The diagnosis of heart failure will be confirmed by a senior cardiologist with a subspecialty interest in heart failure following detailed review of the patient's history, clinical findings and investigations using the following diagnostic criteria:
Signs and symptoms of heart failure
&
- Objective evidence of cardiac dysfunction either by;
Left ventricular ejection fraction of ≤ 50%
or;
Plasma concentrations of N-terminal pro-brain natriuretic peptide (NT-proBNP) >400 pg/mL if in sinus rhythm or > 1000 pg/ml if in atrial fibrillation/flutter and being treated with either oral or intravenous furosemide ≥40 mg/day or equivalent at the time of inclusion.
説明
Inclusion Criteria:
- Age ≥18
- First hospital admission with a diagnosis of HF (as defined below)
- Able and willing to provide informed consent
- Able to undergo CMR
Exclusion Criteria:
- Known or subsequent diagnosis of amyloidosis, sarcoidosis or hypertrophic cardiomyopathy
- Severe valve disease of any type requiring inpatient surgery
- Heart transplant recipient or admitted for cardiac transplantation/ left ventricular assist device
- Clinically apparent myocardial ischemia which requires revascularisation
- Myocardial infarction or revascularisation within the previous 60 days
- Intra cardiac mass which requires surgery
- Active endocarditis
- Septicaemia
- Pregnancy
- Life expectancy <2 years secondary to any other cause (i.e. malignancy)
- Active treatment with chemotherapy
- Severe renal failure (GFR <30)
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：ケースのみ
- 時間の展望：見込みのある
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
All Cause Mortality
時間枠：2 years
|
Number of deaths within the study population
|
2 years
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Rehospitalisation with heart failure
時間枠：2 years
|
Number of Rehospitalisations with heart failure within the study population
|
2 years
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Cardiac arrythmia
時間枠：30 days
|
The number of any cardiac arrhythmia following discharge within the study population
|
30 days
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- CAR0540
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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